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ACTIVE_NOT_RECRUITINGNA

Acceptability of Mobile Applications (Apps) to Enhance Smoking Cessation in a Clinical Tobacco Treatment Program - A Pilot Study

NCT05038852•M.D. Anderson Cancer Center

Summary

We will conduct a small-scale randomized controlled trial (RCT) with 24 adult smokers enrolled in the TTP. Participants will receive either the Free4Good mobile app for positive psychology skills training or a breathing relaxation mobile app control (Breathe2Relax). All participants will be receiving tobacco cessation treatment in the Tobacco Treatment Program at MD Anderson as standard of care.

Detailed Description

The aims of this pilot protocol are to test the adherence, acceptability, user satisfaction, and preliminary efficacy of a smartphone mobile health app, Free4Good, which incorporates skills training in positive psychology vs. a relaxation app, Breathe2Relax (control condition), in a small randomized controlled trial of smokers (N = 24). Adherence will be measured directly through app usage data. Acceptability and user satisfaction will be measured via specific items included on a User Satisfaction Questionnaire. Efficacy outcomes include evidence of increased engagement in positive psychology-related quitting strategies (measured by the Quitting Strategies Questionnaire) and smoking abstinence. Exploratory analyses including covariates such as nicotine dependence, mood, and depressive symptoms may be examined as appropriate, as these measures have been shown to predict abstinence outcomes in a variety of studies.1-4 Changes in mood and/or depressive symptoms may also be characterized

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•MD Anderson patient between the ages of 18 to 65
•current smoker (i.e., at least 1 cigarette or e-cig per day)
•smoking for at least one year,
•willing to set a quit date in the next 30 days,
•not engaged in smoking cessation treatment other than the MDACC Tobacco Treatment Program
•English speaking and ability to read and comprehend English, and 7) currently own an iOS mobile phone (iPhone) using iOS 9.0 or later and reports regular use (at least weekly) of at least 1 iOS app.

Exclusion Criteria

•endorsing current suicidal ideation or intent,
•meeting criteria for a current Major Depressive Episode measured by the PHQ-9,
•any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Collaborator,
•subject considered by the investigator an unsuitable candidate for receipt of a smoking cessation treatment or unstable to be followed up throughout the entire duration of the study.
•Pregnant women will not be excluded from participating in the study and any decisions about potential pharmacotherapy will be done as standard of care in the Tobacco Treatment Program, including a consultation with the medical team and a joint decision-making process with the patient to determine the best course of treatment given all co-morbid medical conditions.

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

April 12, 2019

Primary Completion Date

February 2, 2027

Completion Date

February 2, 2027

Last Updated

January 9, 2026

Enrollment

ACTUAL participants

Conditions

Smoking CessationTobacco

Interventions

smartphone applications

DEVICE

smartphone applications

DEVICE

Noncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers

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E-cigarette UseCigarette Smoking+2 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Acceptability of Mobile Applications (Apps) to Enhance Smoking Cessation in a Clinical Tobacco Treatment Program - A Pilot Study

Inclusion Criteria

Exclusion Criteria

Noncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers

Effects of Smoking on Network Connectivity in Patients With Schizophrenia Symptoms in Scz Patients

The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers

Harm Reduction for Smokers With Mental Illness

Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study

Effects of Tobacco Cut and Nicotine Form on the Abuse Liability of Moist Snuff